NCT06650280

Brief Summary

The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 17, 2024

Last Update Submit

October 18, 2024

Conditions

Keywords

dental implantsrapid osseointegrationearly loading

Outcome Measures

Primary Outcomes (1)

  • rapid osseintegration

    rapid osteointegration of dental implants will be evaluated by the use of Ostell device which measures primary and secondary stability expressed as ISQ measures ranging from zero till 90

    immediately post-operative, 4, 6, and 12 weeks post-operative

Secondary Outcomes (1)

  • marginal bone loss

    immediately after final restoration delivery and one year post-operative

Study Arms (3)

sandblasted acid etched group

EXPERIMENTAL

sandblasted acid etched coated implants will be allocated to this arm

Other: sandblasted acid etched

nano-hydroxyapatite group

ACTIVE COMPARATOR

nano-hydroxyapatite coated implants will be allocated to this arm

Other: nano-hydroxyapatite

hyaluronic acid group

EXPERIMENTAL

hyaluronic acid coated implants will be allocated to this arm

Other: Hyaluronic Acid (HA)

Interventions

hyaluronic acid coated implants will be placed in posterior maxilla to evaluate rapid osseointegration

hyaluronic acid group

nano-hydroxyapatite coated implants will be placed in posterior maxilla to assess rapid osseointegration

nano-hydroxyapatite group

SLA coated implants will be placed in posterior maxilla and implant stability will be evaluated

sandblasted acid etched group

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with missing at least one maxillary posterior tooth
  • Patients free from any systemic disease
  • Patients who approve to be included in the trial and sign the informed consent
  • Patients with no intra-bony defect.
  • Adults aged 18 years old and above

You may not qualify if:

  • Patients who are allergic to titanium
  • Heavy smoker patient
  • Patients receiving chemotherapy or radiotherapy
  • Patients who refused to be included in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, MSA University

Giza, Egypt

Location

Related Publications (1)

  • Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.

    PMID: 17974108BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acidnano-hydroxyapatite-collagen

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mohamed Hamdy, Lecturer

    Faculty of Dentistry, MSA University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral & Maxillofacial Surgery

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 21, 2024

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations